Import Alert 99-32

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 99-32

Published Date: 09/13/2019

Type: DWPE

Import Alert Name:

Reason for Alert:

Review of this Import Alert found contact information to be out of date, ambiguity regarding removal from IA process, and absence of PAC codes. Revision of this Import Alert dated 3/15/2019 addresses these findings. This revision does not change the current firms/products listed on the Red List of this Import Alert. Changes are bracketed by asterisks (***).

NOTE: Revision to this Import Alert dated July 22, 2014 revises the Reason for Alert and Charge sections to change the word "agency" to "agent". Changes are bracketed by three asterisks (***).

As part of FDA's activities intended to protect the health and safety of US consumers, FDA often conducts establishment inspections of foreign manufacturers who produce FDA-regulated articles intended for sale in the US.

As part of FDA's foreign inspection process, the Agency may contact the foreign manufacturer and schedule the establishment inspection; however, there is no such requirement to do so. Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin.

The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel, combined with other evidence, provides an appearance that the firm's products are manufactured, processed, or packed under insanitary conditions.

The Red List identifies firm(s) that have offered FDA-regulated articles for import into the United States and yet refused to allow the completion of an FDA inspection of their foreign establishment(s) for the purpose of determining establishment conditions and compliance with applicable laws and regulations, for example compliance with FDA's Low-Acid Canned Food regulation, 21 C.F.R. Part 113. On the basis of a refusal from the firm(s), listed on the Red List, combined with other evidence, it appears that their articles were manufactured, processed, or packed under insanitary conditions for purposes of section 801(a)(1) of the act; therefore such articles are subject to refusal of admission into the US.

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. Section 306 of FSMA, codified in section 807 of the FD&C Act (21 U.S.C. 384c(b)), provides FDA with the authority to refuse admission of food into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment. For the purposes of this charge, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after such request is submitted, or after such time period, as agreed upon by FDA and the foreign factory, warehouse, or other establishment.

Foreign factories, warehouses, or other establishments who refuse to permit entry of United States inspectors or other individuals, duly designated by the Secretary, to inspect their factories, warehouses, or other establishments will be listed on the Red List of this Import Alert, food products from those facilities are subject to refusal of admission as set forth in section 807 of the FD&C Act.

The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. Section 707 of FDASIA added a new section 501(j) to the FD&C Act, making a drug adulterated if it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or ***agent*** of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection. Articles of drug that have been manufactured, processed, packed, or held in any factory, warehouse, or establishment of which the owner, operator, or ***agent*** has delayed, denied, or limited an inspection, or refused to permit entry or inspection, appear to be adulterated and are subject to refusal under section 801(a)(3) of the FD&C Act.

Guidance:

Districts may detain without physical examination all products from the firm(s) identified on the Red List to this import alert.

NOTE: If an article is subject to Refusal of Admission per Section 801(a)(1) or 807(b) of the FD&C Act, FDA considers submission of analytical results to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801(a)(1) of the FD&C Act precludes reconditioning under Section 801(b) of the FD&C Act.

Products imported from the firm(s) listed on the Red List to this import alert should remain subject to detention without physical examination until an FDA inspection is completed. Firms may provide copies of inspection reports for inspections performed by third parties only to assist FDA in prioritizing inspection requests.

*** To remove a firm’s product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the condition (refusal of FDA inspection) that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act). For guidance on removal from detention without physical examination, refer to FDA’s Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE),” available at: https://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf

If a firm and/or a representative thereof wishes to petition for removal from detention without physical examination under this Import Alert, submit a request (which may include copies of inspection reports for inspections performed by third parties) to schedule an FDA inspection to the following address:***

***Questions or issues on drug import policy related to this Import Alert should be addressed to CDER Imports Exports Compliance Branch at cderimportsexports@fda.hhs.gov.***

***Questions or issues on food import policy related to this Import Alert should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov***

***Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.***

***Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at ORAOISMDSSIMPCOMPLSYSBR@FDA.HHS.GOV.***

Product Description:

PRODUCT:

See Red List

PRODUCT CODE:

See Red List

Charge:

(If the article is from a firm that has refused establishment inspection which, combined with other evidence, provides an appearance that the article has been manufactured, processed, or packed under insanitary conditions):

"The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions."

OASIS CHARGE CODE: REFUSE EI

(If the article is a drug that has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or ***agent*** of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection):

"The article of drug is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under section 501(j) of the FD&C Act."

OASIS CHARGE CODE: DRG REF EI

(If the article is food from a foreign establishment that refuses to permit entry of United States inspectors or other individuals, duly designated by the Secretary, to inspect their facilities):

"The food is subject to refusal of admission pursuant to Section 807 in that the foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment."

OASIS CHARGE CODE: 807REFUSAL

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)

CANADA

Maher Industries Ltd.

Date Published : 12/16/2014

451 Smith Street
, Arthur,
Ontario CANADA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 12/16/2014

60 - - - -- Human and Animal Drugs

Date Published: 12/16/2014

61 - - - -- Human and Animal Drugs

Date Published: 12/16/2014

62 - - - -- Human and Animal Drugs

Date Published: 12/16/2014

63 - - - -- Human and Animal Drugs

Date Published: 12/16/2014

64 - - - -- Human and Animal Drugs

Date Published: 12/16/2014

65 - - - -- Human and Animal Drugs

Date Published: 12/16/2014

66 - - - -- Human and Animal Drugs

Date Published: 12/16/2014

CHINA

Anhui Dangshan Tongtai Foods Co.

Date Published : 01/17/2018

South Side of 310 National Highway , Economic Development Zone
, Dangshan,
Anhui CHINA

Notes: Problem(s);
(GMP) Good Manufacturing Practices;
For Industry 79 and 80 codes; only drug and drug products are subject to DWPE under this notice. These codes are included as the firm has shipped first aid kits containing combination device/drug products.

Notes: Problem(s);
(GMP) Good Manufacturing Practices;
For Industry 79 and 80 codes; only drug and drug products are subject to DWPE under this notice. These codes are included as the firm has shipped first aid kits containing combination device/drug products.

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.

53 L - - -- Skin Care Prep

Date Published: 11/01/2016

Desc: All Drug and Drug Products

Notes: The firm has a history of shipping apparent drug products (i.e. petroleum
jelly) under Industry Code 53. Any products determine to be drug products
shipped under Industry Code 53 are subject to DWPE under this listing.

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 11/01/2016

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.

56 - - - -- Antibiotics (Human/Animal)

Date Published: 11/01/2016

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.

60 - - - -- Human and Animal Drugs

Date Published: 11/01/2016

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.

61 - - - -- Human and Animal Drugs

Date Published: 11/01/2016

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.

62 - - - -- Human and Animal Drugs

Date Published: 11/01/2016

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.

63 - - - -- Human and Animal Drugs

Date Published: 11/01/2016

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.

64 - - - -- Human and Animal Drugs

Date Published: 11/01/2016

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.

65 - - - -- Human and Animal Drugs

Date Published: 11/01/2016

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.

66 - - - -- Human and Animal Drugs

Date Published: 11/01/2016

Notes: All Drug and Drug Products;The firm has a history of shipping apparent drug
products (i.e. petroleum jelly) under Industry Code 53. Any products
determine to be drug products shipped under Industry Code 53 are subject to
DWPE under this listing.